Type 1 DiabetesDiaCon2NCT01444443
DiaCon Overnight Closed-Loop Glucose Control Study
A study of Type 1 Diabetes, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The objective of this in-clinic study is to test our closed-loop glucose control system in patients with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Type 1 diabetes duration > 2 years
- HbA1c < 8%
- Insulin pump user > 1 year
Who cannot join
- Use of medication affecting glucose metabolism
- Pregnancy or nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DiaCon Closed-Loop Study
The objective of this in-clinic study is to test our closed-loop glucose control system in patients with type 1 diabetes.
- Conditions
- Type 1 Diabetes
- Being tested
- Closed-loop control, Open-loop control
- Keywords
- Type 1 diabetes, Glucose control, Closed-loop, Insulin pump, Glucose sensor
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-loop controlDevice
Also called Metronic Veo-pump. DexCom 7+ sensor.
Blood glucose controlled by algorithm
Open-loop controlOther
Blood glucose controlled by patient
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop glucose control | Experimental | Blood glucose controlled by control algorithm. Receives: Device: Closed-loop control |
| Open-loop glucose control | Active comparator | Blood glucose controlled by patient Receives: Other: Open-loop control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hypoglycemic events
Measured: 22:00-07:00
Secondary outcomes (1)
Time spent in euglycemia (3.9-8.0 mmol/l); mean blood glucose level; LBGI
Measured: 22:00-07:00
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Denmark, Novo Nordisk A/S
- Responsible party
- Principal investigator, Signe Schmidt, Hvidovre University Hospital
- Investigators
- Signe Schmidt, MD, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444443
- Sponsor's protocol ID
- 2106-07-0034
- Acronym
- DiaCon2
- Status last verified
- Nov 2012
- First submitted
- 28 Sep 2011
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DiaCon Closed-Loop Study
- ClinicalTrials.gov ID
- NCT01444443
- Acronym / sponsor ID
- DiaCon2 / 2106-07-0034
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Glucose control, Closed-loop, Insulin pump, Glucose sensor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Technical University of Denmark, Novo Nordisk A/S
- Study start
- Nov 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 30 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this in-clinic study is to test our closed-loop glucose control system in patients with type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed-loop glucose control | Experimental | Device: Closed-loop controlBlood glucose controlled by control algorithm. |
| Open-loop glucose control | Active comparator | Other: Open-loop controlBlood glucose controlled by patient |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years
- Type 1 diabetes duration > 2 years
- HbA1c < 8%
- Insulin pump user > 1 year
Key exclusion criteria (2 listed)
- Use of medication affecting glucose metabolism
- Pregnancy or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed-loop controlAlso: Metronic Veo-pump. DexCom 7+ sensor.Blood glucose controlled by algorithm | Device | Closed-loop glucose control |
| Open-loop controlBlood glucose controlled by patient | Other | Open-loop glucose control |
Primary outcome
Number of hypoglycemic events
Time frame: 22:00-07:00
1 secondary outcome
Time spent in euglycemia (3.9-8.0 mmol/l); mean blood glucose level; LBGI
Time frame: 22:00-07:00
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Signe Schmidt, MD principal investigator
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Type 1 Diabetes, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hypoglycemic events (time frame: 22:00-07:00). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2012.